FDA 510(k)

Procellera

Número K: K160783 · 2016-09-07

Data da decisão2016-09-07

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Procellera is the device name listed in this FDA 510(k) record. The listed applicant is Vomaris Innovations, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K160783. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Procellera?

Procellera is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Vomaris Innovations, Inc.. The 510(k) number is K160783.

When did Procellera receive FDA 510(k) clearance?

Procellera received FDA 510(k) clearance on 2016-09-07, under 510(k) number K160783.

Who is the listed applicant for Procellera?

The FDA 510(k) record lists Vomaris Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Procellera?

The FDA product code for Procellera is FRO. This falls under the Anesthesiology category.

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